A Drug Interaction Study of BIIB074 and an Oral Contraceptive Regimen
Status:
Completed
Trial end date:
2018-03-15
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to evaluate the effect of multiple doses of a uridine
diphosphate glucuronosyltransferases (UGT)-inducing oral contraceptive (OC) regimen (ethinyl
estradiol and levonorgestrel) on the PK of BIIB074 at steady state; evaluate the effect of
multiple doses of BIIB074 on the pharmacokinetics(PK) of an OC regimen (ethinyl estradiol and
levonorgestrel) at steady state.
The secondary objective of this study is to evaluate the safety and tolerability of BIIB074
when administered alone and when coadministered with a UGT-inducing OC regimen containing
ethinyl estradiol and levonorgestrel and to evaluate the effect of a UGT-inducing OC regimen
(ethinyl estradiol and levonorgestrel) on the PK of the M13, M14, and M16 metabolites of
BIIB074.